葡萄糖酸依诺沙星注射液无菌检查方法的建立及验证  

Establishment and Validation of the Method of Sterility Test for Enoxacin Gluconate Injection

作　　者：刘栋[1] 汤长明[1] 

机构地区：[1]解放军第153中心医院药械科,郑州450042

出　　处：《中国药房》2015年第9期1263-1265,共3页China Pharmacy

摘　　要：目的:建立和验证葡萄糖酸依诺沙星注射液的无菌检查方法。方法:根据2010年版《中国药典》,采用薄膜过滤法,以0.1%蛋白胨水溶液为冲洗液,考察在不同冲洗液量和在培养基中加入中和剂时,6种阳性对照菌的生长情况。结果:在冲洗液量为每管300 ml、每次冲洗100 ml,使用含0.2 mol/L Mg2+的培养基时,所有阳性对照菌均生长良好。结论:最终确立的葡萄糖酸依诺沙星注射液的无菌检查方法为以大肠埃希菌为阳性对照菌,采用0.1%蛋白胨水溶液冲洗3次(每次100 ml),经薄膜过滤后加入含Mg2+培养基。本法简便、冲洗量相对较少,是葡萄糖酸依诺沙星注射液一种较为理想的无菌检查方法。OBJECTIVE：To establish and validate the method of sterility test for Enoxacin gluconate injection. METHODS：According to Chinese Pharmcopoeia（2010 edition）,membrane filtration method was used and 0.1% peptone water was used as flushing liquid. The growth of 6 positive control bacteria was observed and investigated with different volumes of flushing liquid or adding neutralization into culture medium. RESULTS：All of 6 positive control bacteria grew normally with 300 ml flushing liquid in each tube（100 ml each time）and culture medium containing 0.2 mol/L Mg2 ＋. CONCLUSIONS：The sterility test for Enoxacin gluconate injection was finally established with the positive bacteria of Escherichia coli,flushing three times by 0.1% peptone solution（100 ml each time）and adding medium containing Mg2＋after membrane filtration. The method is simple with less flushing liquid relatively. It is an ideal method for the sterility test of Enoxacin gluconate injection.

关 键 词：葡萄糖酸依诺沙星注射液 无菌检查 方法验证 阳性对照菌 中和剂 

分 类 号：R927.1[医药卫生—药学]